Cleared Traditional

Atlan

K230931 · Dr?gerwerk AG & Co KGaA · Anesthesiology
Jul 2023
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K230931 is an FDA 510(k) clearance for the Atlan, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Dr?gerwerk AG & Co KGaA (Luebeck, DE). The FDA issued a Cleared decision on July 23, 2023, 111 days after receiving the submission on April 3, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K230931 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2023
Decision Date July 23, 2023
Days to Decision 111 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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